An Open Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (PCR)MedDRA version: 14.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-021425-13-CZ
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 5000
*Subjects must have signed an informed consent document indicating that they
understand the purpose of and procedures required for the study and are willing to
participate in the study.
*Written Authorization for Use and Release of Health and Research Study Information (United States [U.S.]
sites only) or Data Protection Consent (European sites only) has been obtained.
* Subjects at sites which are participating in the collection of QoL/MRU data will be
asked to provide written informed consent for the collection of these personal data.
* Age =18 years and male
* Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology
* Received at least one but not more than two cytotoxic chemotherapy
regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel. Treatments containing any taxane with or without additional cytotoxic chemotherapeutics given concurrently, (eg, docetaxel carboplatin) are considered a single prior cytotoxic in the context of eligibility for this study. If a specific taxane is administered more than once (such as when a subject requires a treatment break to resolve toxicity), the entire period of administration of this taxane is considered a single regimen (eg, a subject who received 6 cycles of docetaxel from May to June, followed by
a treatment break and then 4 additional cycles of docetaxel from August to September, would be considered to have received one prior cytotoxic regimen).
* Prostate cancer progression as assessed by the investigator with one of the following:
– PSA progression according to Prostate Cancer Working Group 2 (PCWG2)
criteria
– Radiographic progression in soft tissue according to Response Evaluation Criteria
in Solid Tumors (RECIST) criteria or bone scans with or without PSA
progression.
* Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
* Eastern Cooperative Oncology Group (ECOG) performance status of =2
* Hemoglobin =9.0 g/dL independent of transfusion
* Platelet count =100,000/µL
* Serum albumin =3.0 g/dL
* Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine
clearance = 60 mL/min
* Serum potassium =3.5 mmol/L
* Able to swallow the study drug whole as a tablet
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* Eligible for another study of abiraterone acetate that is open to enrollment. Medical monitor review will be
required to allow enrollment on this study if a subject is eligible for another abiraterone acetate open study
* Received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or
COU-AA-302.
* Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection
* Abnormal liver functions consisting of any of the following:
– Serum bilirubin =1.5 x ULN (except for subjects with documented Gilbert’s
disease, for whom the upper limit of serum bilirubin is 3 mg/dL)
– Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x ULN
* Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood
pressure =95 mmHg); subjects with a history of hypertension are allowed provided
blood pressure is controlled by anti-hypertensive therapy.
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial
thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class
III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline
* Known brain metastasis
* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
* Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE Grade of =1. Chemotherapy induced alopecia and Grade 2 peripheral neuropathy is allowed
* Use of other anticancer therapy including cytotoxic, radionucleotide,
And immunotherapy; diethylstilbestrol; PC-SPES; spironolactone (ie,
ALDACTONE, SPIRONOL); and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
* Prior systemic treatment with an azole drug (eg. fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Day 1
* Condition or situation which, in the investigator's opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method